CompletedNot Applicable

Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

Belgium22 participantsStarted 2022-03-01

Plain-language summary

This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis : * chemical angioplasty * chemical and mechanical angioplasty

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years.
✓. Non-traumatic intracranial hemorrhage (ruptured aneurysm, AVM, or per-procedural complication etc)
✓. Ruptured aneurysm, AVM, intracranial arterial perforation or any bleeding lesion secured with surgical clipping or endovascular intervention.
✓. No contra-indication to both CTP and MRI imaging
✓. Subject or legal representative is able and willing to give informed consent.
✓. Refractory of intracranial arterial vasospastic stenosis requiring an endovascular angioplasty with a severe stenosis defined on CTA or DSA; and/or a significant hypoperfusion defined according to the mismatch profile in stroke or a MTT\>6 seconds. The volume of critically hypoperfused tissue will be based on a time to maximum of the tissue residue function (Tmax) threshold of \>6 sec using the Rapid (or equivalent) software.

Exclusion criteria

✕. Angioplasty by one of the two methods considered as impossible or too risky by the neurointerventionist
✕. Inability to obtain consent from patient or patients relatives
✕. Pregnant women
✕. Less than 18 years of age
✕. Need to use any other device
✕. Vertebro-basilar arteries will not be randomized because of the difficulty to assess the perfusion volume in this territory, but will be treated if necessary according to our local protocol.

What they're measuring

Change in brain hypoperfusion

Timeframe: Change between day 0 and day 1 after the endovascular procedure and randomization

Trial details

NCT IDNCT05268445

SponsorErasme University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Aneurysmal Subarachnoid Hemorrhage trials